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EP1979053A2 - Produit pour traiter la peau et les membranes muqueuses, et procede de preparation associe - Google Patents

Produit pour traiter la peau et les membranes muqueuses, et procede de preparation associe

Info

Publication number
EP1979053A2
EP1979053A2 EP06831681A EP06831681A EP1979053A2 EP 1979053 A2 EP1979053 A2 EP 1979053A2 EP 06831681 A EP06831681 A EP 06831681A EP 06831681 A EP06831681 A EP 06831681A EP 1979053 A2 EP1979053 A2 EP 1979053A2
Authority
EP
European Patent Office
Prior art keywords
mixture
skin
product
hereinbefore
trichloracetic acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP06831681A
Other languages
German (de)
English (en)
Other versions
EP1979053B1 (fr
Inventor
Rossana Castellana
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36658741&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP1979053(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Priority to PL06831681T priority Critical patent/PL1979053T3/pl
Priority to SI200631725T priority patent/SI1979053T1/sl
Publication of EP1979053A2 publication Critical patent/EP1979053A2/fr
Application granted granted Critical
Publication of EP1979053B1 publication Critical patent/EP1979053B1/fr
Priority to CY20141100055T priority patent/CY1114888T1/el
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/22Peroxides; Oxygen; Ozone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/10Anti-acne agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/16Emollients or protectives, e.g. against radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/18Antioxidants, e.g. antiradicals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/20Chemical, physico-chemical or functional or structural properties of the composition as a whole
    • A61K2800/28Rubbing or scrubbing compositions; Peeling or abrasive compositions; Containing exfoliants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/52Stabilizers

Definitions

  • the present invention concerns a product for treating the skin or the mucous membranes, in the medical, aesthetic and/or cosmetic field, and the relative method of preparation.
  • the present invention concerns a product and the relative method to produce it, to be used in the treatment of problems of the skin and the mucous membranes, such as acne, sun damage, sun freckles, pre-cancerous lesions, problems of pigmentation, damage deriving from episodes of scarring, both due to wounds and also to the effects of pathologies, atrophy, hypertrophy, retraction and alteration of the scarring of every part of the body, including the gums, damage caused by ageing, such as wrinkles, sagging of the skin and suchlike.
  • problems of the skin and the mucous membranes such as acne, sun damage, sun freckles, pre-cancerous lesions, problems of pigmentation, damage deriving from episodes of scarring, both due to wounds and also to the effects of pathologies, atrophy, hypertrophy, retraction and alteration of the scarring of every part of the body, including the gums, damage caused by ageing, such as wrinkles, sagging of the skin and suchlike.
  • mucous membrane we mean a membrane that covers the inner face of some organs, such as the vesical mucous, the mucous of the nose and of the intestine, the inner region of the mouth, including the gums, and which is kept continuously moist by the secretion of muciferous glands or of other type of glands. It consists of an epithelium, facing towards the free surface, and an underlying layer of connective tissue, possibly containing muscular fibers and lymphocytes.
  • the skin is divided into two parts: the inner dermis, which mainly contains blood vessels, nerve ends, fibroblastic cells for the biosynthesis of elastin and collagen, immersed in an amorphous substance rich in glycosoaminoglycans, called "fundamental substance"; and the outer epidermis, further divided into the Malpighian layer, formed by a living tissue divided again into basal, spinous and granular, and the corneous layer, formed by a dead tissue, which is the layer visible to the naked eye.
  • the inner dermis which mainly contains blood vessels, nerve ends, fibroblastic cells for the biosynthesis of elastin and collagen, immersed in an amorphous substance rich in glycosoaminoglycans, called "fundamental substance”
  • the outer epidermis further divided into the Malpighian layer, formed by a living tissue divided again into basal, spinous and granular, and the corneous layer, formed by a dead tissue, which is the layer visible to the naked eye.
  • the known indications regarding treatment with TCA concern both medical affections such as widespread actinic damage with contiguous actinic keratosis, that is, the circumscribed proliferation of the corneous layer of the epidermis; they also concern aesthetic conditions such as the ageing of the face and sun freckles.
  • the depth of the desired tissue necrosis is therefore correlated to the concentration of the TCA.
  • a solution comprising TCA in a concentration of less than 25% w/w entails the exfoliation of the epidermis, whereas a solution comprising TCA at about 30 — 40% w/w causes dermal necrosis of 0.3 — 0.5 mm, the depth normally required to renew skin with actinic damage.
  • the in-depth penetration of TCA, to the level of the papillary dermis is fundamental for renewing the tissue of the epidermis and dermis and is signaled by the start of a subcutaneous edema in the region treated, associated with a whitening of the skin, due to the denaturing of the skin proteins .
  • the effects of medium-depth chemical peeling with TCA are, among others: improvement of sun elastosis and replacement with thick and homogenized bands of dermal collagen, that is, neo-collagenogenesis, with cytological and architectural normalization of the epidermis.
  • TCA is an extremely aggressive agent which, when it is very concentrated, on the one hand brings the benefits of exfoliation and renovation of the epidermis, and on the other hand, in order to obtain these benefits, has serious side effects, since the TCA itself must inevitably penetrate in depth, passing through the epidermis as far as the dermis, and thus causing structural damage to the epidermis and the dermis, due to the effect of the hydrogen ions of the TCA which cause denaturation and precipitation of the epidermal proteins, giving rise to the known visual effect of whitening of the surface skin, also known as "white frost".
  • the denaturation of the proteins produces an eschar, that is, a plaque of altered tissue which forms in association with a necrotizing process of the skin; curing this will give as a result the desired skin renewal; however, this happens over 7 — 10 days, during which interval the skin of the patient's face is covered by a thick "crust" of a brown and/or grayish color, clearly impeding the patient normal social life.
  • Another purpose is to perfect a method to produce said product for treating the skin and the mucous membranes.
  • the Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages .
  • a product for treating the skin and the mucous membranes according to the present invention can be obtained by means of a method that comprises the following steps: a) to make available a suitable quantity of trichloracetic acid (CCl 3 COOH or TCA); b) to make available a suitable quantity of hydrogen peroxide (H 2 O 2 ); c) to make a first mixture of said trichloracetic acid of step a) with said hydrogen peroxide of step b); d) to make available a determinate quantity of basic compound, able to achieve a buffer of said first mixture comprising said trichloracetic acid; e) to add, to said first mixture, said basic compound of step d) in order to buffer, that is, to fix the value of pH of said first mixture comprising said trichloracetic acid at a desired value.
  • the final pH of said product is comprised between about 2.3 and 2.6.
  • the pH of the product is about 2.5.
  • the above basic compound used is at least a compound chosen from a group comprising ammonia (NH 3 ), triethanolamine and suchlike, or mixtures thereof.
  • the basic compound is used in stoichiometric quantity, or in excess, according to requirements, in order to achieve a buffer effect of said first mixture comprising said trichloracetic acid:
  • the basic compound is ammonia, suitable to diminish the aggressiveness of the TCA.
  • the use of ammonia or triethanolamine prevents the risk of evolution of toxic metabolites from the buffer reaction of the trichloracetic acid.
  • the production of the first mixture in step c) involves a reaction of an endothermic type.
  • the TCA of step a) is supplied substantially pure, except for a minimum quantity of humidity due to the high hygroscopicity of the TCA itself, for example in the form of crystals, usually very deliquescent.
  • the TCA in step a) can be obtained, on the contrary, starting from precursors of the TCA itself, that is, by means of a step of chlorination of acetic acid or chloracetic acid, in the presence of visible light, UV rays or a suitable catalyst.
  • the TCA of step a) is mixed with hydrogen peroxide to give said first mixture.
  • the first mixture comprises TCA, said TCA having a concentration comprised in a range of between about 15 and 50%, preferably between 25 and 40 % w/w, even more preferably between 30 and 35 % w/w.
  • the TCA in said first mixture is in a concentration of about 33% w/w; advantageously in this case there is an optimum compromise between the TCA' s typical characteristics of exfoliating the skin and its capacity for stimulating the dermis in order to renovate the tissues.
  • the hydrogen peroxide is mixed to the TCA in step b), so that the composition of hydrogen peroxide in the first mixture is present to a concentration comprised between about 85 and 50% w/w, preferably between about 75 and 60% w/w, even more preferably between about 70 and 65% w/w.
  • the composition of hydrogen peroxide in the first mixture is about 67% w/w.
  • a gelling step is performed in which a thickening agent is added, for example silica based, such as AEROSIL ® 200 Pharma, advantageously resistant to the pH values obtained, or Sepigel (Seppic) or others, to make the product spreadable; it is also possible to add glycerin, to improve the compatibility of the product and absorption into the skin.
  • a thickening agent for example silica based, such as AEROSIL ® 200 Pharma, advantageously resistant to the pH values obtained, or Sepigel (Seppic) or others, to make the product spreadable; it is also possible to add glycerin, to improve the compatibility of the product and absorption into the skin.
  • the final product after the gelling step, has a pH value, measured with a standard method that provides to dilute the sample, even greater than the starting pH comprised between about 2.3 and 2.6, for example comprised between about 5 and 6.
  • the final product may not comprise trichloracetic acid but may comprise the relative reaction products .
  • the product according to the present invention has good characteristics of renewing the tissues of the epidermis and dermis.
  • Applicant has also developed a method for the application of the product according to the present invention, on damaged skin; according to the method of application, the product is applied by means of direct and prolonged massage on the skin, or by means of applications with a brush and suchlike .
  • TCA has reached the level of the dermis papillae and therefore there follows a stimulation and renewal of the dermis, with an increase of the neo-collagenogenesis, but without altering or damaging the surface of the skin.
  • Applicant has hypothesized an action mechanism of the product according to the present invention, connected to the different speed and depth of penetration of the hydrogen peroxide and the TCA or the relative reaction products.
  • the hydrogen peroxide has high tropism and rapidly enters into the skin cells, but substantially only into the surface skin cells.
  • the action against the effects of acne occurs both in a surface action of an exfoliating type, which frees the outlet ducts, and also in an in-depth action in the pustules, penetrating deeply and acting selectively on the inflamed sebaceous follicle in order to stimulate repair of the pustules without scarring.
  • the product according to the present invention adds a surprising anti-septic action on the local bacterial flora, due to the synergic effect of the TCA and the hydrogen peroxide.
  • the results were unexpectedly positive with patients under treatment with isotretinoin, because generally isotretinoin is a drug which, giving alterations to the cicatrisation of the lesions, counter- indicates any other ablative peeling.
  • isotretinoin is a drug which, giving alterations to the cicatrisation of the lesions, counter- indicates any other ablative peeling.
  • the repeated medical application of the product according to the present invention impedes and contrasts the onset of scars.
  • Applicant also used the product experimentally for the treatment of recent depressed scars, such as for example resulting from pathologies such as chicken pox, with considerable results in recovering connected scars.
  • Applicant experimentally and successfully used the product according to the present invention for the treatment of unwanted dermal-epidermal pigmentations, such as chloasma or hyper-pigmentary reactivity in high phototypes, without any side effects, whereas traditional peeling, by causing inflammation, can aggravate such aesthetic problems.
  • unwanted dermal-epidermal pigmentations such as chloasma or hyper-pigmentary reactivity in high phototypes
  • traditional peeling by causing inflammation
  • Applicant successfully used the product according to the present invention experimentally for the treatment of photo-ageing of the skin.
  • the effect of stimulating the dermis was positive, with an optimum result in improving the skin texture, the coloring and luminosity of the skin and a drastic reduction of dilated pores.
  • the present invention gave a surprising improvement in skin tone, shown immediately by the onset of the edema, which persisted over months with the repetition of the application in subsequent sittings for treating neo- collagenogenesis.
  • an improvement was found in the result and duration of the re-absorbable fillers, such as for example collagen, polylactic acid, hyaluronic acid, since it increases compactness of the dermis and prevents these materials from being dispersed.
  • the present invention can be used in the field of dentistry, thanks to the combined anti-septic and renovating action due to neo-collagenogenesis. It is clear that modifications and/or additions of parts and/or steps may be made to the product for the skin and mucous membranes and method as described heretofore, without departing from the scope of the present invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Birds (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne un procédé pour préparer un produit pour traiter la peau et les membranes muqueuses, qui comprend les étapes consistant à rendre disponible une quantité adaptée d’acide trichloroacétique, à rendre disponible une quantité adaptée de peroxyde d'hydrogène, préparer un premier mélange de l'acide trichloroacétique et du peroxyde d'hydrogène, rendre disponible une quantité déterminée du composé basique capable de produire un effet tampon sur l'acide trichloroacétique compris dans le premier mélange, et ajouter le composé basique au premier mélange afin de tamponner le premier mélange comprenant l'acide trichloroacétique.
EP06831681.9A 2005-12-13 2006-12-12 Produit pour traiter la peau et les membranes muqueuses, et procede de preparation associe Active EP1979053B1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
PL06831681T PL1979053T3 (pl) 2005-12-13 2006-12-12 Produkt do leczenia skóry i błon śluzowych oraz odnośny sposób wytwarzania
SI200631725T SI1979053T1 (sl) 2005-12-13 2006-12-12 Proizvod za zdravljenje kožnih in sluzničnih membran in ustrezni postopek za pripravo
CY20141100055T CY1114888T1 (el) 2005-12-13 2014-01-22 Προϊον για τη θεραπεια του δερματος και των βλεννογονων μεμβρανων, καθως και σχετικη μεθοδος παρασκευης

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000211A ITUD20050211A1 (it) 2005-12-13 2005-12-13 Prodotto per il trattamento della pelle relativo procedimento di preparazione
PCT/IB2006/003558 WO2007069024A2 (fr) 2005-12-13 2006-12-12 Produit pour traiter la peau et les membranes muqueuses, et procede de preparation associe

Publications (2)

Publication Number Publication Date
EP1979053A2 true EP1979053A2 (fr) 2008-10-15
EP1979053B1 EP1979053B1 (fr) 2013-10-23

Family

ID=36658741

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06831681.9A Active EP1979053B1 (fr) 2005-12-13 2006-12-12 Produit pour traiter la peau et les membranes muqueuses, et procede de preparation associe

Country Status (13)

Country Link
US (1) US10874883B2 (fr)
EP (1) EP1979053B1 (fr)
JP (1) JP5344926B2 (fr)
AU (1) AU2006325083B2 (fr)
CY (1) CY1114888T1 (fr)
DK (1) DK1979053T3 (fr)
ES (1) ES2441440T3 (fr)
HR (1) HRP20140063T1 (fr)
IT (1) ITUD20050211A1 (fr)
PL (1) PL1979053T3 (fr)
PT (1) PT1979053E (fr)
SI (1) SI1979053T1 (fr)
WO (1) WO2007069024A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022117499A1 (fr) 2020-12-01 2022-06-09 Rossana Castellana Formulations pour la cicatrisation de lésions traumatiques de la peau et de muqueuses

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2930727B1 (fr) * 2008-04-30 2012-10-05 Evolution Dermatologique Lab Composition pour le traitement des etats seborrheiques.
PT2407151T (pt) * 2010-07-15 2019-12-09 Progressare Medinvest B V Composição para o tratamento de lesões da pele e/ou unhas
IT201600111171A1 (it) * 2016-11-04 2018-05-04 Uras Cosmetics S R L S Kit per il trattamento della pelle e suo impiego
IT201700104536A1 (it) * 2017-09-19 2019-03-19 Cmed Aesthetics Srl Prodotti topici con sistema bifasico
IT202200025614A1 (it) * 2022-12-14 2024-06-14 Rfc S R L Nuove formulazioni topiche per la stimolazione della crescita dei capelli contenenti forme ossidate di acidi carbossilici a basso peso molecolare
WO2025133708A2 (fr) * 2023-12-23 2025-06-26 Specbio, Inc. Utilisation thérapeutique de compositions et procédés de traitement épidermique

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022117499A1 (fr) 2020-12-01 2022-06-09 Rossana Castellana Formulations pour la cicatrisation de lésions traumatiques de la peau et de muqueuses

Also Published As

Publication number Publication date
JP5344926B2 (ja) 2013-11-20
SI1979053T1 (sl) 2014-02-28
PT1979053E (pt) 2014-01-07
WO2007069024A2 (fr) 2007-06-21
JP2009519315A (ja) 2009-05-14
AU2006325083A1 (en) 2007-06-21
WO2007069024A3 (fr) 2007-10-04
HRP20140063T1 (hr) 2014-02-28
AU2006325083B2 (en) 2012-03-15
DK1979053T3 (da) 2014-01-20
US10874883B2 (en) 2020-12-29
PL1979053T3 (pl) 2014-04-30
US20090110646A1 (en) 2009-04-30
ITUD20050211A1 (it) 2007-06-14
EP1979053B1 (fr) 2013-10-23
CY1114888T1 (el) 2016-12-14
ES2441440T3 (es) 2014-02-04

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